Yvonne Lungershausen, Chief Executive Officer
All companies are under pressure to contain fixed costs. Both large and small pharmaceutical companies depend on service providers to perform tasks, solve problems, and improve efficiency. While drug manufacture takes a back seat in Phase I, it comes to the forefront during late-phase development. There are defined activities and industry regulations (ICH, FDA, EMEA, CDER), leading to a longer and more complicated outsourcing program. Consequently, a different regulatory strategy is necessary along with a higher level of Good Manufacturing Practices (GMP) compliance and, as regulatory scrutiny increases, the risk of a clinical hold is more probable. Along these lines, Avance Clinical—a well renowned Australian CRO, with extensive experience across every phase of clinical research, complemented with a full suite of in-house clinical research services, ensures that trials are delivered on time and budget.
"We aim to give clients unparalleled service to optimise the time and cost-effective completion of projects. It's as simple as that," adds Yvonne Lungershausen, the Chief Executive Officer at Avance Clinical. The company offers premium services in an established clinical trial ecosystem that includes world-class Investigators and Sites able to access specialised patient groups. In addition, Avance Clinical possesses over two decades of experience in offering seamless end-to-end in-house clinical research services, supporting its clients' portfolio with clinical project management, trial monitoring, local safety reporting, medical writing, data management, statistical and pharmacokinetic services, CDISC and external and internal auditing around the globe. Regarded as the Australian CRO partner of choice by Biotech companies worldwide, Avance's client portfolio extends across North America, Canada, New Zealand, Asia and Europe with these companies predominantly situated in the private biotech and pharmaceutical sector.
As one of the leading Australian CRO, Avance Clinical has an array of clinical research experience in covering prominent therapeutic areas related to Oncology, Ophthalmology, Haematology, Otorhinolaryngology (ENT), Dermatology and Pediatric/Neonatology, to name a few.
We aim to give clients unparalleled service to optimise the time and cost-effective completion of projects. It's as simple as that
Today, the Thebarton-based company has become one of Australia's leading Contract Research Organisations—facilitating quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. Furthermore, Avance is committed to providing best-in-class clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Specialising in working with biotech companies to execute Phase 1 and Phase 2 clinical trials, Avance's service portfolio includes clinical project management, clinical trial monitoring, drug safety reporting, medical writing, data management, statistical and pharmacokinetic services, and external auditing. Approximately 96 per cent of Avance's work is supporting small to medium-sized biotechnology companies executing Phase 1 and Phase 2 trials, extending across North America, Canada, New Zealand, Europe and Asia and being accepted by all of the major regulatory agencies around the globe.
Avance Clinical has recently commended the Australian industry for exceptional COVID-19 management which indicates that Australia leads the world in maintaining clinical trials business. The company's Chief Strategy Officer, Ben Edwards presented at BIO Digital 2020 on the many benefits of running trials in Australia. Edwards has pointed out, "Approximately 96% of our work is supporting small to medium-sized biotechnology companies executing Phase 1 and Phase 2 trials. Our client base currently extends across North America, Canada, New Zealand, Europe and Asia. Australia is a well-established location for international clinical trials, and our management of the COVID-19 crisis has made it an even more attractive trials destination." This statement alone proves to be a testament to the strength of Avance's impressive COVID-19 management and its overall commitment to quality.